Japanese Study Evaluating the Effects of Telithromycin in Children With Community-Acquired Pneumonia
NCT00638859 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2009-10-02
Summary
The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5-7 days in children with community-acquired pneumonia (CAP).
Secondary objectives are to assess Pharmacokinetics, Efficacy and Acceptability of telithromycin 20 mg/kg qd for 5-7 days in children with CAP.
Conditions
Interventions
- DRUG
-
Telithromycin (HMR3647)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
CSD · Sanofi
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 6 Months
- Max Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-03-31
- Primary Completion
- 2004-10-31
- Completion
- 2004-10-31
Countries
- Japan
Study Locations
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